(102 days)
Not Found
No
The device description and performance studies focus on the mechanical function and clinical efficacy of a physical pessary device, with no mention of AI/ML components or data processing related to learning or adaptation.
Yes
The device is indicated for the temporary management of stress urinary incontinence and provides mid-urethral support, which is a therapeutic action aimed at alleviating a medical condition.
No
This device is a vaginal pessary designed for the management of stress urinary incontinence by providing physical support. Its intended use is to treat or alleviate symptoms, not to diagnose a condition.
No
The device description clearly describes a physical, intra-vaginal device made of soft, flexible material that is inserted and removed, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a physical pessary inserted into the vagina to provide mechanical support for stress urinary incontinence. It does not analyze any biological samples or provide diagnostic information based on laboratory testing.
- Intended Use: The intended use is for the "temporary management" of stress urinary incontinence, which is a physical treatment rather than a diagnostic process.
The description clearly indicates a physical device for mechanical support, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females.
Vaginal Pessary device is designed to be used by any woman, who suffers from stress urinary incontinence.
Product codes (comma separated list FDA assigned to the subject device)
HHW
Device Description
a device which is placed intra-vaginally to provide mid-urethral support. The soft, flexibie device is inserted via an applicator, looks like a tampon applicator, and once placed in the vagina, expands to provide mild tension on the vaginal walls. It is has flexible arms that continue to provide support during normal body movement. It is removed via a pull string, like a tampon. It is single use, disposable and may be worn up to 8 hours at a time.
It is available in multiple sizes to accommodate differences in vaginal anatomy and severity of urine leakage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-vaginally
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A fifty (50) participant safety and efficacy study was performed. It measured objective and subjective end-points.
Objective Efficacy end-point
- Reduction in pad weight Objective at least a 70% reduction .
- 94% of participants obtained % reduction of over 70% (p80% reduction of A pad weight.
Subjective Efficacy end-points
- Participant's perception of being dry .
- 92% considered themselves dry when compared to the first week and the last few days of use
- Leak Score Quality of Life (QoL) questionnaire the total score, decreasing from 21.26 to ● 5.3, pre-trial vs. post-trial, respectively.
Safety Testing
- We monitored all participants for any problems and adverse events. ●
- . The number of reported adverse events was 6.6% which is lower than other predicate study results.
- Biocompatibility testing per ISO 10993-1 has been demonstrated. .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Johnson & Johnson - Introl ® - Bladder Neck Support K930618 and K965040
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).
0
K060524
page 1 of 2
510(k) Summary
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 15-May-06
JUN - 9 2006
| ConTIPI Ltd. | |
|---|---|
| 99 Hahistadrut Ave. | Tel - 011-972-4-8470113 |
| Haifa 31250 ISRAEL | Fax - 011-972-4-8490824 |
| Official Contact -- | Nir Sinai - Project Manager |
|---|---|
| Proprietary or Trade Name - | |
| Common/Usual Name - | Intra-vaginal stress incontinence device |
| Classification Name -- | Vaginal pessary |
| Device -- | |
| Predicate Devices -- | Johnson & Johnson - Introl ® - Bladder Neck Support K930618 and K965040 |
JUN - 6 2002Device Description --
a device which is placed intra-vaginally to provide mid-urethral support. The soft, flexibie device is inserted via an applicator, looks like a tampon applicator, and once placed in the vagina, expands to provide mild tension on the vaginal walls. It is has flexible arms that continue to provide support during normal body movement. It is removed via a pull string, like a tampon. It is single use, disposable and may be worn up to 8 hours at a time.
It is available in multiple sizes to accommodate differences in vaginal anatomy and severity of urine leakage.
| Indications for Use -- | indicated for temporary management of genuine (mild, moderate and severe) stress urinary incontinence in females. |
|---|---|
| Patient Population -- | designed to be used by any woman, who suffers from stress urinary incontinence. |
| Environment of Use -- | No limitations |
1
1K060526
Page 1 of 2
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2 15-May-06
| Contraindications -- | Patients should not use if: |
|---|---|
| Vaginal infection or lacerations are present Urinary tract infections Severely atrophic vagina Recovering from recent vaginal surgery Have difficulty inserting a vaginal tampon |
- Abnormal vaginal bleeding .
- During monthly menstruation period .
- During coitus .
- Consult your doctor regarding use during pregnancy ◆
Clinical Testing Effectiveness and Safety --
A fifty (50) participant safety and efficacy study was performed. It measured objective and subjective end-points.
Objective Efficacy end-point
- Reduction in pad weight Objective at least a 70% reduction .
- 94% of participants obtained % reduction of over 70% (p80% reduction of A pad weight.
Subjective Efficacy end-points
- Participant's perception of being dry .
- . 92% considered themselves dry when compared to the first week and the last few days of use
- Leak Score Quality of Life (QoL) questionnaire the total score, decreasing from 21.26 to ● 5.3, pre-trial vs. post-trial, respectively.
Safety Testing
- We monitored all participants for any problems and adverse events. ●
- . The number of reported adverse events was 6.6% which is lower than other predicate study results.
- Biocompatibility testing per ISO 10993-1 has been demonstrated. .
Substantial Equivalence -
The device based upon a comparison to the predicate and clinical testing has been demonstrated that it is substantially equivalent.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 9 2006
ConTIPI Ltd. % Mr. Paul E. Dryden Regulatory Consultant ProMedic. Incorporated 6329 W. Waterview Ct. MCCORDSVILLE IN 46055-9501
Re: K060526
Trade/Device Name: Vaginal Pessary Regulation Number: 21 CFR § 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: HHW Dated: May 15, 2006 Received: May 16, 2006
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "FDA Centennial" in the center. The seal also includes the years "1906-2006" and the phrase "Protecting and Promoting Public Health" written in cursive. The logo is black and white.
3
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Page 1 of 1
510(k) Number: K060526
Device Name:
Indications for Use:
Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females.
Vaginal Pessary device is designed to be used by any woman, who suffers from stress urinary incontinence.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Vaginal Pessary device
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________